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Logo OPTI-FREE® Daily Cleaner (Suspension)

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

OPTI-FREE® Daily Cleaner (Suspension)

COMPOSITION:
OPTI-FREE
® Daily Cleaner is a buffered, isotonic suspension.
Each mL contains:
Polymeric beads 25 mg
Preservatives:
Edetate disodium 0,1% (w/v)
Polyquad (polyquaternium-1) 0,001% (w/v)

PHARMACOLOGICAL CLASSIFICATION:
A.34 Contact lens preparations.

PHARMACOLOGICAL ACTION:
OPTI-FREE Daily Cleaner loosens and removes accumulations of film, deposits and debris from the contact lenses.

INDICATIONS:
OPTI-FREE Daily Cleaner is indicated for use with all lens care disinfection systems in the daily cleaning of all contact lenses.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients in OPTI-FREE Daily Cleaner.

WARNINGS:
OPTI-FREE Daily Cleaner is not intended for use directly in the eye. Serious damage to the eye and loss of vision may result from wearing contaminated or damaged contact lenses. Immediately consult an eye care practitioner to identify the cause of any unexplained eye discomfort, watering, vision change or redness of the eye and to begin any necessary treatment.

DOSAGE AND DIRECTIONS FOR USE:
General:
Always wash and rinse hands before handling contact lenses.
Always handle the same lens, the right or left, first in order to avoid mixups.
Clean and disinfect lenses each time after removal.
After reinserting lenses, always empty lens storage case, rinse and allow to air dry.
Clean:
SHAKE OPTI-FREE Daily Cleaner WELL.
After removing the first lens, place it in the palm of the hand.
Then place one or two drops of OPTI-FREE Daily Cleaner on each lens surface.
Rub the lens for about 20 seconds either in the palm using the forefinger of the other hand or between the thumb and forefinger.
Be sure to clean each side of the lens.
Rinse:
Apply a few drops of the rinsing solution to each lens surface and rub for one or two seconds.
Thoroughly rinse both surfaces of the lens by holding the lens in a steady stream of rinsing solution for 10 seconds while gently rubbing the lens.
Disinfect:
After cleaning, contact lenses should always be disinfected in the manner recommended by an eye care practitioner.
Prepare the empty storage case as directed in the instructions for lens disinfection.
Put the lens into the correct chamber (section) marked for the lens of the storage case.
Fill the chamber, completely covering the lens with the disinfecting solution.
Tightly close the chamber of the lens storage case.
Repeat this procedure for the second lens.
Disinfect and store lenses in accordance with the lens care procedures recommended by an eye care practitioner.
Precautions:
Lenses should never be placed directly in the eyes from the cleaning solution. Lenses must always be rinsed and disinfected after each cleaning procedure.
NOTE: Failure to rinse the lenses may cause discomfort due to debris remaining on the lenses.
This product is not intended for storage of lenses.
Never reuse this solution.
Never touch the dropper tip of the container to any surface since this may contaminate the contents.
Keep container tightly closed when not in use.
Use before the expiration date marked on the container and carton.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The following problems may occur while wearing contact lenses:
Eye stinging, burning or itching (irritation).
Excessive watering (tearing) of the eyes.
Unusual eye secretions.
Redness of the eyes.
Reduced sharpness of vision (visual acuity).
Blurred vision.
Sensitivity to light (photophobia).
Dry eyes.
If you notice any of the above problems, remove and examine the lenses. Do not reinsert a damaged lens. If the problem stops and lenses appear to be undamaged, thoroughly clean, rinse and disinfect the lenses and reinsert them. IMMEDIATELY remove the lenses and consult an eye care practitioner for proper identification of the problem and treatment to avoid serious eye damage.
No finality has been reached on the long-term safety of soft contact lens preparations.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-Effects above.

IDENTIFICATION:
Opaque, white to off-white suspension.

PRESENTATION:
OPTI-FREE Daily Cleaner is supplied in sterile 15 mL and 30 mL plastic bottles filled to 12 mL and 24 mL, respectively, to allow sufficient space for shaking.

STORAGE INSTRUCTIONS:
Store at room temperature (8° - 30°C).
Avoid excessive heat.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
X/34/18

NAME AND BUSINESS ADDRESS OF APPLICANT:
Alcon Laboratories (SA) (Pty) Ltd
65 Peter Place
Bryanston Extension 13
2191

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 October 2004

0504

Updated on this site: January 2008
Source: Pharmaceutical Industry

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